Wound Infection, SurgicalNCT01540279
Clinical Outcome in View of Surgical Site Infection (SSI) With Antibacterial Skin Sutures
An observational study of Wound Infection, Surgical, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Background: Poor wound healing and the development of surgical site infection (SSI) continue to occur and remain a significant cause of disability among operated patients. In spite of the substantial advances in our understanding of the epidemiology, pathogenesis and prevention it remains one of the most common… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection, Surgical
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with required open abdominal surgery will be consecutively enrolled.Data of emergency patients are recorded separately as well as patients with a contaminated or dirty-infected (class III-IV) operative wound classified according to CDC guidelines on surgical wound classification1 further Patients with implanted foreign material such as mesh or vascular prosthesis.
Who may be able to join
- All patients from the Visceral Department of Basel University Hospital requiring open abdominal surgery. Open abdominal surgery is defined as: opened peritoneal cavity
Who cannot join
- factors limiting the ability to co-operate in the study;
- absence of signed informed consent before entering the study;
- people with mental disorders;
- pregnant women;
- participants under 18 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Surgical Department of University Hospital Basel, Switzerland
Basel, Canton of Basel-City, 4031
About this study
Official title: Do Antibacterial Skin Sutures Reduce Surgical Site Infections After Open Abdominal Surgery?
Background: Poor wound healing and the development of surgical site infection (SSI) continue to occur and remain a significant cause of disability among operated patients. In spite of the substantial advances in our understanding of the epidemiology, pathogenesis and prevention it remains one of the most common complications in conventional abdominal surgery with an incidence in the literature between 4% and 17%. As it is known that surgical sutures potentiate the development of wound infection the search for an ideal suture material, suitable for all purposes has been pursued by surgeons for decades.
Hypothesis: In line with in-vitro results the investigators hypothesize that the use of antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after open abdominal surgery Methods: To prevent microbial colonization of suture material in operative wounds and therefore to prevent SSI, triclosan-coated poliglecaprone 25 suture materials with antibacterial activity will be tested against un-coated suture material for skin closure after open abdominal surgery of 200 patients. The study is planed as a single center, randomized controlled trial. After ethical approval the patients will be consecutively enrolled from 2011 to 2012 in the Department of Visceral Surgery, University Hospital Basel, Switzerland. The patients will be followed for 30 days (day 3,7 and 30) to detect and document wound complications. Wound complications will be classified according to Center for Disease Control and Prevention Standard guidelines. Data will be collected and the rate of SSI will be analysed in both groups.
Expected value of the proposed project: If the investigators can confirm the proposed hypothesis in our study this could be a promising and feasible approach to lower SSI after open abdominal surgery and might be also used in other surgical fields. By lowering the rate of SSI the investigators might offer a new and cost saving procedure to the surgical community.
- Conditions
- Wound Infection, Surgical
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort one with abdominal wall closure with Monocryl | Not described | |
| Cohort two with abdominal wall closure with Monocryl plus | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Infection, SurgicalStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi Misteli, MD, Study chair, Surgical Department of University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540279
- Sponsor's protocol ID
- University Hospital Basel
- Status last verified
- Mar 2015
- First submitted
- 22 Feb 2012
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Antibacterial Skin Sutures Reduce Surgical Site Infections After Open Abdominal Surgery?
- ClinicalTrials.gov ID
- NCT01540279
- Acronym / sponsor ID
- University Hospital Basel
- Conditions
- Wound Infection, Surgical
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Poor wound healing and the development of surgical site infection (SSI) continue to occur and remain a significant cause of disability among operated patients. In spite of the substantial advances in our understanding of the epidemiology, pathogenesis and prevention it remains one of the most common complications in conventional abdominal surgery with an incidence in the literature between 4% and 17%. As it is known that surgical sutures potentiate the development of wound infection the search for an ideal suture material, suitable for all purposes has been pursued by surgeons for decades.
Hypothesis: In line with in-vitro results the investigators hypothesize that the use of antibacterial skin sutures with triclosan poliglecaprone 25 reduces the rate of SSI after open abdominal surgery Methods: To prevent microbial colonization of suture material in operative wounds and therefore to prevent SSI, triclosan-coated poliglecaprone 25 suture materials with antibacterial activity will be tested against un-coated suture material for skin closure after open abdominal surgery of 200 patients. The study is planed as a single center, randomized controlled trial. After ethical approval the patients will be consecutively enrolled from 2011 to 2012 in the Department of Visceral Surgery, University Hospital Basel, Switzerland. The patients will be followed for 30 days (day 3,7 and 30) to detect and document wound complications. Wound complications will be classified according to Center for Disease Control and Prevention Standard guidelines. Data will be collected and the rate of SSI will be analysed in both groups.
Expected value of the proposed project: If the investigators can confirm the proposed hypothesis in our study this could be a promising and feasible approach to lower SSI after open abdominal surgery and might be also used in other surgical fields. By lowering the rate of SSI the investigators might offer a new and cost saving procedure to the surgical community.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort one with abdominal wall closure with Monocryl | – | – |
| Cohort two with abdominal wall closure with Monocryl plus | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with required open abdominal surgery will be consecutively enrolled.Data of emergency patients are recorded separately as well as patients with a contaminated or dirty-infected (class III-IV) operative wound classified according to CDC guidelines on surgical wound classification1 further Patients with implanted foreign material such as mesh or vascular prosthesis.
Key inclusion criteria (1 listed)
- All patients from the Visceral Department of Basel University Hospital requiring open abdominal surgery. Open abdominal surgery is defined as: opened peritoneal cavity
Key exclusion criteria (5 listed)
- factors limiting the ability to co-operate in the study;
- absence of signed informed consent before entering the study;
- people with mental disorders;
- pregnant women;
- participants under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
Related trials for Wound Infection, Surgical
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Misteli, MD study chair
Surgical Department of University Hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Infection, Surgical, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.